the Investigation Into Beneficial Effects of High-dose Interferon Beta 1-a, Compared to Low-dose Interferon Beta 1-a in Moderate to Severe Covid-19

Phase 2

• Conditions: Covid19
• Interventions: Drug: High dose Interferon-beta 1a; Drug: Lopinavir/Ritonavir; Drug: Low dose Interferon-beta 1a

• Registration Number: NCT04521400
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

The present study is a randomized clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.

Detailed Description

According to previous studies, IFN-β has strong antiviral activity and also has an acceptable safety profile. Based on possible therapeutic effects, we decided to lead an Investigation into Beneficial Effects of high-dose Interferon Beta 1a, Compared to low-dose Interferon Beta 1a (the base therapeutic regimen) in Moderate to Severe COVID-19.

Previous studies demonstrate that IFN-β 1a could be used against some coronaviruses including avium infectious, bronchitis virus, murine hepatitis virus, and SARS- CoV because they are susceptible in vitro or in vivo. In a current study, the efficacy of IFN-β 1a in COVID-19 patients were evaluated, and they found than IFN-β 1a reduced the disease symptoms.

The present study is a randomized clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran.

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-18
• Study First Submitted QC: 2020-08-19
• Last Update Submitted: 2020-08-19
• Study Start: 2020-08-20
• Study First Posted: 2020-08-20
• Last Update Posted: 2020-08-20
• Primary Completion: 2020-09-04
• Study Completion: 2020-09-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age ≥ 18
• COVID-19 Confirmed Cases (Either RT-PCR or CT Scan Confirmed)
• at least one of the following: radiation contactless body temperature ≥37.5, cough, shortness of breath, nasal congestion/ discharge, myalgia/arthralgia, diarrhea/vomiting, headache or fatigue on admission.
• Time of onset of the symptoms should be acute (Days ≤ 14)
• NEWS2 ≥ 1 on admission (National Early Warning Score 2)

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Exclusion Criteria

• Refusal to participate expressed by patient or legally authorized representative if they are present
• Patients using drugs with potential interaction with Lopinavir/Ritonavir or Interferon-β 1a
• Pregnant or lactating women.
• History of alcohol or drug addiction in the past 5 years.
• Blood ALT/AST levels > 5 times the upper limit of normal on laboratory results.
• The patients who were intubated less than one hours after admission to the hospital

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm1	High dose Interferon-beta 1a	Lopinavir /Ritonavir +high dose Interferon-β 1a
Arm1	Lopinavir/Ritonavir	Lopinavir /Ritonavir +high dose Interferon-β 1a
Arm2	Lopinavir/Ritonavir	Lopinavir /Ritonavir + Low dose Interferon-β 1a
Arm2	Low dose Interferon-beta 1a	Lopinavir /Ritonavir + Low dose Interferon-β 1a

Primary Outcome Measures

Name	Time	Method
Time to clinical improvement	From date of randomization until 14 days later	Improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R\&D. Geneva: World Health Organization) or discharge from the hospital, whichever came first.

Secondary Outcome Measures

Name	Time	Method
Incidence of new mechanical ventilation use	From date of randomization until 14 days later
Mortality	From date of randomization until 14 days later	If the patient dies, we have reached an outcome
SpO2 Improvement	Days 1, 2, 3, 4, 5, 6, 7 and 14	Pulse-oxymetry
Duration of hospitalization	From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 14 days
Cumulative incidence of serious adverse events	Days 1, 2, 3, 4, 5, 6, 7 and 14	With the incidence of any serious adverse effects, the outcome has happened